Administration of taurolidine-citrate lock solution for prevention of central venous catheter infection in adult neutropenic haematological patients: a randomised, double-blinded, placebo-controlled trial (TAURCAT)

Trials. 2018 May 2;19(1):264. doi: 10.1186/s13063-018-2647-y.


Background: Catheter-related bloodstream infection (CRBSI) is one of the most frequent complications in patients with cancer who have central venous catheters (CVCs) implanted and is associated with substantial morbidity and mortality. Taurolidine is a non-antibiotic agent with broad-spectrum antimicrobial activity, which has been used as a lock solution to prevent CRBSI in some settings. However, little is known about its usefulness in high-risk adult neutropenic patients with cancer. This prospective randomised clinical trial aims to test the hypothesis that taurolidine-citrate lock solution is more effective than placebo for preventing catheter infection in neutropenic haematological patients.

Methods: This study is a prospective, multicentre, randomised, double-blinded, parallel, superiority, placebo-controlled trial. Patients with haematological cancer who are expected to develop prolonged neutropenia (> 7 days) and who have a non-tunnelled CVC implanted will be randomised to receive prophylactic taurolidine-citrate-heparin solution using a lock technique (study group) or heparin alone (placebo group). The primary endpoint will be bacterial colonisation of the CVC hubs. The secondary endpoints will be the incidence of CRBSI, CVC removal, adverse events, and 30-day case-fatality rate.

Discussion: The lock technique is a preventive strategy that inhibits bacterial colonisation in the catheter hubs, which is the initial step of endoluminal catheter colonisation and the development of infection. Taurolidine is a nontoxic agent that does not develop antibiotic resistance because it acts as an antiseptic rather than an antibiotic. Taurolidine has shown controversial results in the few trials conducted in cancer patients. These studies have important limitations due to the lack of data on adult and/or high-risk neutropenic patients, the type of catheters studied (tunnelled or ports), and the lack of information regarding the intervention (e.g. dwelling of the solution, time, and periodicity of the lock technique). If our hypothesis is proven, the study could provide important solid evidence on the potential usefulness of this preventive procedure in a population at high risk of CRBSI, in whom this complication may significantly impair patient outcome.

Trial registration: ISRCTN, ISRCTN47102251 . Registered on 9 September 2015.

Keywords: Antibiotic lock technique; Catheter-related bloodstream infection; Central venous catheter infection; Haematological patients; Lock solution; Neutropenia; Taurolidine-citrate.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Anti-Infective Agents / administration & dosage*
  • Anti-Infective Agents / adverse effects
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects*
  • Catheter-Related Infections / diagnosis
  • Catheter-Related Infections / microbiology
  • Catheter-Related Infections / mortality
  • Catheter-Related Infections / prevention & control*
  • Catheterization, Central Venous / adverse effects*
  • Catheterization, Central Venous / instrumentation
  • Catheterization, Central Venous / mortality
  • Catheters, Indwelling / adverse effects*
  • Central Venous Catheters / adverse effects*
  • Citrates / administration & dosage*
  • Citrates / adverse effects
  • Device Removal
  • Double-Blind Method
  • Equivalence Trials as Topic
  • Hematologic Neoplasms / drug therapy*
  • Hematologic Neoplasms / mortality
  • Humans
  • Multicenter Studies as Topic
  • Neutropenia / chemically induced*
  • Neutropenia / diagnosis
  • Neutropenia / mortality
  • Prospective Studies
  • Risk Factors
  • Spain
  • Taurine / administration & dosage
  • Taurine / adverse effects
  • Taurine / analogs & derivatives*
  • Thiadiazines / administration & dosage*
  • Thiadiazines / adverse effects
  • Time Factors
  • Treatment Outcome


  • Anti-Infective Agents
  • Antineoplastic Agents
  • Citrates
  • Thiadiazines
  • Taurine
  • taurolidine